EMA Issues Guideline for Wording of Therapeutic Indication

The European Medicines Agency (EMA) released a guidance developed by Committee for Medical Products for Human Use (CHMP) on the wording of therapeutic indications is consistent across products.

This guide has been prepared to support a consistent approach in the process of defining Therapeutic Indication(s) during the assessment of centralised applications for new active substances or new indications.

Recently, the Agency engaged with different stakeholders with respect to the interpretation of the wording of the indication in different therapeutic areas. The therapeutic indication is the primary information on the use of a medicine. It should clearly state the disease/condition and population that a medicine is intended to treat.

Specifically, the eight-page guide is aimed at providing reviewers with a more consistent approach to defining therapeutic indications and clarifying the framework for assessing indications to promote more consistent wording of therapeutic indications in Section 4.1 of the summary of product characteristics (SmPC).

Within the guide, EMA lays out five elements of the indication for reviewers to consider, including the target disease or condition; target patient population; the product’s place in therapy; whether the product is intended for monotherapy or use in combination with other therapies; and whether there are any other mandatory conditions for the product’s use.

The guide also provides a template for wording the therapeutic indication that takes the various components into account:

“<Diagnostic use >or <Preventive> or <Symptomatic, curative or disease modifying (if applicable)> <treatment of> <{severity criteria if applicable}> <{target disease or condition}> in <{age group}> patients < {restrictions to patient population, if applicable}> <{restrictions in terms of therapeutic option or prior therapy, or other restrictions, if applicable}> <in combination with other medicinal products <{list relevant combinations, if applicable}><in monotherapy> <{Mandatory conditions of product usage not covered more appropriately in other parts of the SmPC}>”

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